This technical information report provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO\/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.<\/p>\n
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| 1<\/td>\n | AAMI\/ISO TIR11137-4:2022\/(R)2023; Sterilization of health care products\u2014Radiation\u2014Part 4: Guidance on process control <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | AAMI Technical Information Report ANSI Registration <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Background of AAMI adoption of ISO\/TS 11137-4:2020 <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 1 Scope 2 Normative references 3 Terms, definitions, and symbols <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4 Principles applied in validating and controlling an irradiation process 4.1 General 4.2 Use of the dose measurement at the monitoring location 4.2.1 General 4.2.2 Dmon as an indirect measurement of dose to product <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.2.3 Dmon as a process monitor 4.2.4 Dmin or Dmax as a direct measurement of dose to product 4.3 Monitoring of critical process parameters <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Table 1\u2014Process parameters critical to radiation sterilization 5 Establishing process target doses 5.1 Inputs and steps in establishing a process target dose 5.1.1 General <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Figure 1\u2014Inputs and steps in establishing a process target dose 5.1.2 Process validation inputs (installation, operational and performance qualification) 5.1.3 Additional inputs <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.1.4 Determine \u03c3process 5.1.5 Product dose specifications 5.1.6 Select coverage factor k 5.1.7 Setting process target doses 5.1.8 Analyse process output 5.1.9 Review 5.2 Performance qualification outputs 5.2.1 General <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.2.2 Experimental design for PQ <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.2.3 Processing categories 5.3 Components of \u03c3process 5.3.1 General <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.3.2 Components related to measurement uncertainty 5.3.2 Components related to measurement uncertainty <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.3.3 Components related to process variability 5.3.4 Combining components of uncertainty <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.3.5 Reducing \u03c3process Table 2\u2014Potential components of \u03c3process and actions to reduce them <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 5.4 Establishing process target doses 5.4.1 Coverage factors 5.4.2 Process factors <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 5.4.3 Choice of target processing parameters 5.4.4 Assessing process capability <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 6 Routine monitoring and control 6.1 General 6.2 Product handling 6.2.1 Receipt of product 6.2.2 Loading 6.2.3 Unloading <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 6.2.4 Storage 6.2.5 Shipment 6.3 Processing of product 6.3.1 General 6.3.2 Processing parameters <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 6.3.3 Location of dosimeters 6.3.4 Partially filled containers 6.3.5 Process interruptions 6.3.5.1 Interpreting dosimeters following a process interruption 6.3.5.2 Process interruptions which require the movement of irradiation containers <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 6.3.5.3 Process interruptions for products capable of supporting microbial growth 6.3.6 Transitions between densities 6.4 Special processing conditions 6.4.1 Off-carrier processing 6.4.2 Irradiation of product under modified environmental conditions 6.4.2.1 General 6.4.2.2 Dosimetric considerations for validating and processing in a modified environment <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 6.4.2.3 Process considerations when using refrigerants 6.4.2.4 Process interruptions when using modified environmental conditions 6.5 Process output interpretation 6.5.1 General 6.5.2 Using an acceptance range based on Dmonster and Dmonmax,acc <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Figure 3\u2014Acceptance range based on Dmonster and Dmonmax,acc 6.5.3 Using an acceptance range with alert and action levels <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Figure 4\u2014Process acceptance ranges with action and alert levels 6.5.4 Using an acceptance range based on process monitoring <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Figure 5\u2014Expected probability distribution functions for an example process where Dtarget is set to Dtargetlower 6.5.5 Investigation of a dose measurement outside of expectation <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 6.6 Collection and analysis of data 6.6.1 General 6.6.2 Dosimeter data trending <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Figure 6\u2014Monitoring dosimeter value histogram for an example process 6.6.3 Parametric data trending <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 6.6.4 Statistical process control <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Figure 7\u2014Process control chart for an example irradiator, trended over time 7 Release of product from the irradiation process <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 8 Maintaining process effectiveness 8.1 General 8.2 Assessment of changes made to the product 8.3 Assessment of changes made to the equipment <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex A (informative) Examples of setting process target dose ranges and interpretation of process output A.1 General Table A.1\u2014Example matrix <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | A.2 Example 1 A.2.1 Example description A.2.2 Process specification A.2.3 PQ dose measurements Table A.2\u2014Example 1 dose mapping data Table A.3\u2014Example 1 dose mapping ratios Table A.4\u2014Example 1 dose and ratio averages <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | A.2.4 Components of \u03c3process A.2.5 Process factors <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | A.2.6 Process target dose range calculation <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Figure A.1\u2014Variation of minimum and maximum dose to product during operation at Dtarget = Dtargetlower (solid line) and Dtarget = Dtargetupper (dashed line) for both steady state and with transitions taken into consideration A.2.7 Example of application of an acceptance range <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Figure A.2\u2014Variation of dose to the monitoring position during steady state operation at the chosen process target dose for an acceptance range between Dmonster and Dmonmax,acc A.2.8 Additional considerations A.3 Example 2 A.3.1 Example description <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | A.3.2 Process specification A.3.3 PQ dose measurements Table A.5\u2014Example 2 dose mapping data Table A.6\u2014Example 2 dose mapping ratios Table A.7\u2014Example 2 dose and ratio averages A.3.4 Components of \u03c3process <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | A.3.5 Process factors A.3.6 Process target dose range calculation <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Figure A.3\u2014Variation of minimum and maximum dose to product during operation at Dtarget = Dtargetlower (solid line) and Dtarget = Dtargetupper (dashed line) A.3.7 Example of application of an acceptance range <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Figure A.4\u2014Variation of dose to the monitoring position during operation at the chosen parameters for an acceptance range between Dmonster and Dmonmax,acc A.3.8 Additional considerations A.4 Example 3 A.4.1 Example description <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | A.4.2 Process specification A.4.3 PQ dose measurements Table A.8\u2014Example 3 dose mapping data Table A.9\u2014Example 3 dose mapping ratios Table A.10\u2014Example 3 dose and ratio averages A.4.4 Components of \u03c3process <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | A.4.5 Process factors A.4.6 Process target dose range calculation <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Figure A.5\u2014Variation of doses to minimum and maximum in product and expected variation of monitoring dose during operation at Dtarget = Dtargetlower A.4.7 Example of application of an acceptance range <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | Figure A.6\u2014Variation of dose to the monitoring positions during operation at the chosen parameters for an acceptance range based on process monitoring A.4.8 Additional considerations A.5 Example 4 A.5.1 Example description <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | A.5.2 Process specification A.5.3 PQ dose measurements Table A.11\u2014Example 4 dose mapping data averages Table A.12\u2014Example 4 dose mapping ratios averages A.5.4 Components of \u03c3process <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | A.5.5 Process factors A.5.6 Process target dose range calculation <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Figure A.7\u2014Variation of minimum and maximum dose to product during operation at Dtarget = Dtargetlower (solid line) and Dtarget = Dtargetupper (dashed line) A.5.7 Example of application of an acceptance range <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | Figure A.8\u2014Variation of dose to the monitoring position during operation at the chosen parameters for an acceptance range based on alert and action levels A.5.8 Additional considerations Table A.13\u2014Example 4 rules for investigation <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | A.6 Example 5 A.6.1 Example description A.6.2 Process specification A.6.3 PQ dose measurements Table A.14\u2014Example 5 dose mapping data Table A.15\u2014Example 5 dose mapping ratios Table A.16\u2014Example 5 dose and ratio averages <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | A.6.4 Components of \u03c3process A.6.5 Process factors A.6.6 Process target dose range calculation <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Figure A.9\u2014Variation of minimum and maximum dose to product during operation at Dtarget = Dtargetlower (solid line) and Dtarget = Dtargetupper (dashed line) A.6.7 Example of application of an acceptance range <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | Figure A.10\u2014Variation of dose to the monitoring position during operation at the chosen parameters for an acceptance range based on action and alert levels A.6.8 Additional considerations <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI\/ISO TIR11137-4:2022 (R2023) – Sterilization Of Health Care Products -Radiation – Part 4: Guidance On Process Control<\/b><\/p>\n |